Titanium Prepared Platelet-rich Fibrin in Bone Regenerati... | NCT06135077

Studies
Titanium Prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation

NCT06135077

Sponsor

Hams Hamed Abdelrahman

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Sinus Lifting

Interventions

T-PRF alone
T-PRF/Xenograft

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2021Actual

Primary Completion Date

Mar 21, 2023Actual

Completion Date

Mar 21, 2023Actual

First Submitted Date

Nov 11, 2023

First Submission Date that Met QC Criteria

Nov 11, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2023

Last Update Posted Date

Nov 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria UniversitySponsor-Investigator

Lead Sponsor

Hams Hamed AbdelrahmanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination.

This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T-PRF	Experimental		Other: T-PRF alone
T-PRF/xenograft	Active Comparator		Other: T-PRF/Xenograft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
T-PRF alone	Other	T-PRF is the material to be tested in this study as an alternative to classical bone graft	T-PRF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in pain level	measuring level of pain using visual analog scale (VAS) 0-10, where 0 reading indicates no pain and 10 reading reflects the most severe pain.	up to 2 weeks
Change in bone volume	pre opertaive and post operative CBCT	up to 3 months
Change in bone denisty	pre opertaive and post operative CBCT	up to 3 months
Change in bone height	pre opertaive and post operative CBCT	up to 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Systemically in a healthy condition.
Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
Non-smokers.
Good oral hygiene as indicated by plaque and bleeding scores

Exclusion Criteria:

Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
Acute maxillary sinusitis.
Patients administering any antibiotics or regular anti-inflammatory drugs.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University		Alexandria			Egypt